Oral ManifestationsCARDEC-BCNCT06961890
Change in Hygiene and Sugar Comsuption Habits After Use of Cognitive Behavioral Therapy in Pediatric Dentistry in Twins
A study testing Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits in people with Oral Manifestations and Child Behavior, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this study is to verify the changing habits and their maintenance after using cognitive behavioral therapy, exploring factors that may be associated with these stages and the moment in which they occur. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations, Child Behavior, Adolescent Behavior
- What is being tested?
- Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2021to 2 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Twin children born at the Hospital de Clínicas de São Paulo between 2007 and 2014;
- Children whose mothers were followed up at the Multiple Pregnancy Unit;
- Guardians who sign the informed consent form;
- Children who sign the assent form.
Who cannot join
- Children whose families that cannot be contacted by phone call, email, or social media;
- Children with medical or psychological conditions that prevent safe participation in the dental research.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia da Universidade de São Paulo
São Paulo, 05508-000
About this study
The objective of this study is to verify the changing habits and their maintenance after using cognitive behavioral therapy, exploring factors that may be associated with these stages and the moment in which they occur.
Read the detailed description
The objective of this clinical trial is to verify the time until changing habits and their maintenance after using cognitive behavioral therapy, exploring the following factors that may be associated with these stages and the moment in which they occur:
- Evaluate the cost-effectiveness of guidance based on cognitive behavioral therapy in relation to changes aimed at oral hygiene and diet habits, through a before and after study;
- Investigate individual and contextual preferences associated with adherence and maintenance of behaviors associated with oral health (diet and oral hygiene) through a Discrete Choice Experiment (DCE)
- Measure the effect of retaining hygiene and diet guidance on pairs who did not submit the calendar and on those who submitted the calendar.
- Being tested
- Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits
- Keywords
- clinical study, cognitive behavioral therapy, oral health, twins, motivational guidance, preference patients
- Medical subject headings
- Oral Manifestations, Child Behavior, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habitsBehavioural
The twin pairs will also receive guidance on healthy sugar consumption and oral hygiene habits, as the first intervention among the dental interventions received. For the baseline assessment, each participant answered a questionnaire about their diet the day before and about oral hygiene, in addition to demonstrating how they perform it. Thus, the cognitive behavioral theory was applied, so that the participant can record the goals achieved weekly and monthly.
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral therapy | Experimental | All participants will receive a standardized orientation for changing oral health habits using principals of cognitive behavioral therapy Receives: Behavioral: Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing hygiene habits and sugar consumption in children and adolescents
Assessed using a 12-point checklist performed at baseline and at 6 month follow-ups
Measured: 6 months
Secondary outcomes (2)
Preference for attributes associated with adherence to oral health-related behavior
It will be measured after 12 months of the intervention (guidance and motivation) applied to the twins through a Discrete Choice Experiment
Measured: 24 months
Maintenance hygiene habits and sugar consumption in children and adolescents
Assessed using a 12-point checklist performed at baseline and at 12, 18 and 24 month follow-ups, in which it will be assessed whether there was improvement, worsening or return to initial conditions.
Measured: 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start2 Jun 2021
- Primary completion11 Sep 2023
- Study completion2 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ManifestationsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, Principal investigator, University of Sao PauloEdgard M Crosato, Study director, University of Sao PauloThais GO Machado, Study chair, University of Sao PauloFausto M Mendes, Study director, University of Sao PauloLaura RA Pontes, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961890
- Sponsor's protocol ID
- CARDEC-TWINS-BC
- Acronym
- CARDEC-BC
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected on pregnancy, parental sociodemographics (age, sex), alloparental care, and twin characteristics (age, sex, zygosity), using questionnaires and registry data (birth weight, ICU admission, chorionicity, gestational age, fetal growth, complications). Caries lesions and indicators of physical, cognitive, and emotional development will be monitored. Behavioral and physiological data will be collected before and during a dental procedure. Instruments include the Danish Twin Registry Zygosity Questionnaire, Environmental Sensitivity, Socialization Goals, Alabama Parenting, Twin Relationship, Childhood Adversity, Quality of Life, MCDAS-f, Emotion Regulation Checklist, and identity fusion. Additional data: caries detection (ICDAS), physical (height, weight), cognitive (Raven), figure drawings, videos, facial temperature (thermal camera), voice recordings, and saliva swabs. Metadata will follow USP's Open Access Policy, including DOI, title, authors, and deposit details.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Hygiene and Sugar Comsuption Habits After Use of Cognitive Behavioral Therapy in Pediatric Dentistry in Twins
- ClinicalTrials.gov ID
- NCT06961890
- Acronym / sponsor ID
- CARDEC-BC / CARDEC-TWINS-BC
- Keywords
- clinical study, cognitive behavioral therapy, oral health, twins, motivational guidance, preference patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to verify the changing habits and their maintenance after using cognitive behavioral therapy, exploring factors that may be associated with these stages and the moment in which they occur.
Detailed description
The objective of this clinical trial is to verify the time until changing habits and their maintenance after using cognitive behavioral therapy, exploring the following factors that may be associated with these stages and the moment in which they occur:
- Evaluate the cost-effectiveness of guidance based on cognitive behavioral therapy in relation to changes aimed at oral hygiene and diet habits, through a before and after study;
- Investigate individual and contextual preferences associated with adherence and maintenance of behaviors associated with oral health (diet and oral hygiene) through a Discrete Choice Experiment (DCE)
- Measure the effect of retaining hygiene and diet guidance on pairs who did not submit the calendar and on those who submitted the calendar.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy | Experimental | Behavioral: Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habitsAll participants will receive a standardized orientation for changing oral health habits using principals of cognitive behavioral therapy |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Twin children born at the Hospital de Clínicas de São Paulo between 2007 and 2014;
- Children whose mothers were followed up at the Multiple Pregnancy Unit;
- Guardians who sign the informed consent form;
- Children who sign the assent form.
Key exclusion criteria (2 listed)
- Children whose families that cannot be contacted by phone call, email, or social media;
- Children with medical or psychological conditions that prevent safe participation in the dental research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habitsThe twin pairs will also receive guidance on healthy sugar consumption and oral hygiene habits, as the first intervention among the dental interventions received. For the baseline assessment, each participant answered a questionnaire about their diet the day before and about oral hygiene, in addition to demonstrating how they perform it. Thus, the cognitive behavioral theory was applied, so that the participant can record the goals achieved weekly and monthly. | Behavioural | cognitive behavioral therapy |
Primary outcome
Changing hygiene habits and sugar consumption in children and adolescents
Time frame: 6 months
Assessed using a 12-point checklist performed at baseline and at 6 month follow-ups
2 secondary outcomes
Preference for attributes associated with adherence to oral health-related behavior
Time frame: 24 months
Maintenance hygiene habits and sugar consumption in children and adolescents
Time frame: 12, 18, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Yes. Data will be collected on pregnancy, parental sociodemographics (age, sex), alloparental care, and twin characteristics (age, sex, zygosity), using questionnaires and registry data (birth weight, ICU admission, chorionicity, gestational age, fetal growth, complications). Caries lesions and indicators of physical, cognitive, and emotional development will be monitored. Behavioral and physiological data will be collected before and during a dental procedure. Instruments include the Danish Twin Registry Zygosity Questionnaire, Environmental Sensitivity, Socialization Goals, Alabama Parenting, Twin Relationship, Childhood Adversity, Quality of Life, MCDAS-f, Emotion Regulation Checklist, and identity fusion. Additional data: caries detection (ICDAS), physical (height, weight), cognitive (Raven), figure drawings, videos, facial temperature (thermal camera), voice recordings, and saliva swabs. Metadata will follow USP's Open Access Policy, including DOI, title, authors, and deposit details.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana M Braga principal investigator
University of Sao Paulo
Edgard M Crosato study director
University of Sao Paulo
Thais GO Machado study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits in people with Oral Manifestations and Child Behavior, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing hygiene habits and sugar consumption in children and adolescents (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.